Xoran Minicat CT Scanners Recalled for Dose Rate Specification Failures
Xoran Technologies is recalling 320 Minicat CT Scanners because they failed to meet specifications for dose rate. The devices were distributed worldwide and in the US.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a failure to meet specifications but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Xoran Technologies, Inc. is recalling 320 units of the Xoran Minicat00202 CT Scanners. The recall is due to the devices failing to meet the manufacturer's specifications for a dose rate of 125 ± 3 kVp.
The recall is based on 18 complaints received, which indicated that the dose rates were either on the high or low end of the specified range. The affected units were distributed worldwide and nationwide in the United States.
The source text does not specify specific actions for consumers or healthcare providers beyond the notification of the defect.
The recalled product
- Product
- Xoran Minicat00202
- Manufacturer
- Xoran Technologies, Inc.
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- minicat
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Xoran Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Xoran Technologies, Inc.
See all →- HighXoran Minicat CT Scanners Recalled for Dose Rate Failures
FDA (Devices) · 2013-11-06
- HighXoran MiniCAT CT Scanner Recalled for Gantry Rotation Failure
FDA (Devices) · 2013-11-06
- ModerateXoran MiniCAT CT Scanner Recalled for Dose Rate Non-Compliance
FDA (Devices) · 2013-11-06
- HighXoran Mini CT Scanner Recalled for Dose Rate Specification Failures
FDA (Devices) · 2013-11-06
- ModerateXoran MiniCAT CT Scanners Recalled for Dose Rate Specification Failures
FDA (Devices) · 2013-11-06